OncoMatch/Clinical Trials/NCT04678362
TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma
Is NCT04678362 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Talazoparib + Avelumab for urothelial carcinoma.
Treatment: Talazoparib + Avelumab — The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced/metastatic urothelial carcinoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage IV, T4B, N0, M0, ANY T, N1-N3, M0, ANY T, ANY N, M1
Metastatic disease required
Documented Stage IV disease (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1) not candidate to a curative treatment with surgery or radiotherapy at the start of first-line platinum-based chemotherapy.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy (cisplatin, carboplatin) — first-line for advanced/metastatic disease
Patient must have completed prior to inclusion a platinum-based (cisplatin or carboplatin) polychemotherapy for at least 4 cycles of chemotherapy (until 6 cycles maximum) and have a stable disease or a partial response (PR) or a complete response (CR) from the chemotherapy according to RECIST 1.1 criteria
Cannot have received: PARP inhibitor
Any previous treatment with PARP inhibitor
Cannot have received: immunotherapy
Any previous treatment with ... any immunotherapy (e.g. anti-CTLA-4 or anti-PDL1/ PD1)
Cannot have received: chemotherapy
Patient who has previously received more than one line of chemotherapy for advanced/metastatic urothelial carcinoma
Lab requirements
Blood counts
Hemoglobin ≥ 10.0 g/dL (patient may have been transfused before inclusion); ANC ≥1.5 x 10^9/L; Platelet count ≥100 G/l
Kidney function
creatinine clearance estimated using the CKD equation of ≥ 40 mL/min
Liver function
Total bilirubin ≤1.5 x institutional ULN; AST/ALT ≤2.5 x ULN unless liver metastases are present in which case they must be ≤5x ULN
Normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: Hemoglobin ≥ 10.0 g/dL ... Platelet count ≥100 G/l ... Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) ... AST/ALT ≤2.5 x ULN unless liver metastases are present in which case they must be ≤5x ULN ... creatinine clearance estimated using the CKD equation of ≥ 40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04678362 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PARP inhibitor, immunotherapy, chemotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV or T4B, N0, M0 or ANY T, N1-N3, M0 or ANY T, ANY N, M1 is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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